Responsible Person

Are you ready to combine your passion for quality and logistics in the dynamic role of Responsible Person? Discover below the challenges and rewards that come with this role at H.Essers.

YOUR CHALLENGES

As an RP, you play a crucial role in ensuring the quality and safety of the pharmaceutical products we store and transport. You are responsible for the continuous improvement of the quality systems for pharmaceutical products within H.Essers and you function as a contact point to government agencies, to guarantee good quality to our customers.

What this means specifically:

In relation to GDP activities:

• Implementation and maintenance of the quality management system
• Management of authorized activities and the accuracy and quality of their records
• Implementation and maintenance of the training program
• Coordination and execution of any recall operations as requested and initiated by the customer
• Management of customer complaints
• Qualification of customers, suppliers and approval of subcontracted activities
• Management of the self-inspection program
• Documentation of the delegated duties, if any, and their duration
• Management of returned, rejected, recalled and falsified medicinal products, according to the final disposition decision of the customer
• Adherence to any additional requirements imposed on certain products by national law

In relation to The Royal Decree of 06.09.2017 regulating narcotics and psychotropic substances:

• Have adequate knowledge of the legislation on narcotic drugs and psychotropic substances
• Be able to be present at the place of activities within a reasonable time when their presence is required there
• Be responsible for monitoring compliance with the obligations laid down in this Royal Decree
• Be responsible for the necessary reporting to the FAGG as stipulated in the Royal Decree
• Immediately inform the FAGG of the cessation of activities

YOUR TALENTS

• As described in the Royal Decree of 14 December 2006 on medicinal products for human and veterinary Use Art. 84, § 1-4 for QP, and Art. 95, § 2 for Responsible Person - Pharmacist or Master Degree in pharmaceutical sciences, physician or Master in medical sciences, or veterinary sciences, chemistry, biochemistry or biology
• 1 to 2 years’ experience in the distribution, secondary packaging and physical importation of medicinal products

Knowledge of and training in EU GDP Guidelines (2013/C 343/01), EU GMP Guidelines (Eudralex Volume 4), EU API GDP Guidelines (2015/C 95/01), EU GDP Guidelines for Veterinary Medicinal Products (2021/1248), Falsified Medicines Directive (Directive 2011/62/EU), The Royal Decree of 06 Sep 2017, The Royal Decree regulating drug precursors of 20 jan 2025, The Royal Decree of 12 Apr 1974 on certain transactions involving substances with hormonal, anti-hormonal, anabolic, beta-adrenergic, anti-infectious, antiparasitic, and anti-inflammatory effects

• You have strong analytical and problem-solving skills
• The ability to work independently and make decisions is very important
• Finally, you communicate fluently in both English and Dutch

YOUR REWARD

• Your competitive salary is supplemented by attractive benefits
• You can count on a dynamic and stimulating work environment in which you’ll make a significant contribution
• Supported by our vision of 'Lifelong Learning', the H.Essers Academy offers you a free choice of various training courses that contribute to your personal development
• Your physical and mental health are strengthened through H.Essers' Fit2Grow health program
• Your greatest asset is without doubt your place within the strong H.Essers family

7500 REASONS TO CHOOSE H.ESSERS

• Family values: have provided a strong foundation of trust and commitment for both employees and customers since 1928
• Job security: in a rapidly changing world
• Ambitious team: with 7500 dedicated colleagues, we strive for excellence and have an abundance of ambition and opportunity
• Innovation: in our processes and services, enabling us to serve our customers ever more efficiently and sustainably
• Sustainable international growth: recognizing our social, economic, and environmental responsibilities as an organization to have a positive impact on society as a whole
• Diversity and inclusion: are crucial to a healthy and productive work environment and are actively embraced within H.Essers

These are just a few reasons why H.Essers is an attractive choice, we are eager to discover your reason(s).